Shanghai Apolo Medical Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization, incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as: vascular lesions and dental procedures. The "VELAS II-30A/30B" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialists including: Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including Vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental Procedures, Laser assisted lipolysis.
The Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization, incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as: vascular lesions and dental procedure. The "VELAS II-30A/30B" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including Vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental Procedures, Lase assisted lipolysis.
The Diode Laser Therapy Device is a desktop device which utilizes a semiconductor diode with invisible infrared radiation as a laser source (980nm). The laser power is delivered to the treatment via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system and laser system.
Summary parsed at:2026-06-01 05:55:24 UTC
Medical Diode Laser Systems
K191349 references 1 predicate/reference device
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